Home » News

IMW 2009 - Doctors Clarify Standards For Clinical Trial Reporting

2 Comments By
Published: Feb 21, 2009 10:15 pm

As the number of clinical trials on multiple myeloma increases, doctors are asking for more uniform reporting measures.  Maintaining these standards is important both for comparing different therapies and for assessing the validity and reliability of results.

One consensus panel for the upcoming International Myeloma Workshop spent the past year developing guidelines for the reporting of results from clinical trials.  The definitions are largely built from standards used in current practice and include terms found in many published reports.

First, the guidelines outline definitions for patient populations as relapsed, refractory, or relapsed and refractory.  These definitions may be used to determine eligibility in future clinical trials.  Clinical reports should also specify to which drugs the patients have been relapsed and/or refractory.

Second, how well each patient's disease responds to treatments should be ranked according to the International Myeloma Working Group (IMWG) uniform response criteria, with additional clarifications.  The six types of patient responses range from the most favorable to the least favorable (complete response to progressive disease, respectively).  The IMWG criteria were developed to be similar to the European Group for Blood and Bone Marrow Transplant (EBMT) published criteria.

Third, measures for the effectiveness of the drugs are defined.  According to the panel, one of the most important measures of efficacy is the length of time between the start of treatment and disease progression.

Access more detailed information by reading the Guidelines for the Uniform Reporting of Clinical Trials on the International Myeloma Workshop Web site.

Tags: , ,


Related Articles:

2 Comments »

  • Phichai Kanitcharaskul said:

    Dear Sir,

    We cannot access to Guidelines for the Uniform Reporting of Clinical Trials on the International Myeloma Workshop Web site. Could you give us a proper solution please.

    Phichai Kanitcharaskul,MD.
    Hematologist, Bangkok, Thailand

  • Julie Shilane said:

    At this time, the Guidelines for the Uniform Reporting of Clinical Trials seem to be available as a webcast on the International Myeloma Foundation's website.